On February 27, 2018 MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, reported a corporate progress update and financial results for the year ended December 31, 2017 (Press release, MacroGenics, FEB 27, 2018, View Source [SID1234524243]).

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"We have had multiple advances in our portfolio of product candidates recently," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "In addition to margetuximab passing an interim futility analysis for the SOPHIA Phase 3 metastatic breast cancer study, a combination of margetuximab with an anti-PD-1 agent has shown encouraging activity in the treatment of gastric cancer patients in a Phase 2 study. Furthermore, we continue to enroll relapsed/refractory acute myeloid leukemia (AML) patients in the flotetuzumab dose expansion study following the promising results that were presented at recent medical conferences. As we continue to advance these and our other candidates, we look forward to presenting additional data in 2018 and defining future development strategies across our portfolio."

Key Pipeline Updates

Margetuximab. Recent highlights related to the Company’s Fc-optimized monoclonal antibody that targets the human epidermal growth factor receptor 2, or HER2, include:

Phase 3 Metastatic Breast Cancer Study. The pivotal SOPHIA study is evaluating the efficacy of margetuximab plus chemotherapy compared to trastuzumab plus chemotherapy in approximately 530 relapsed/refractory HER2-positive metastatic breast cancer patients. In January 2018, the Company announced the completion of a pre-planned interim futility analysis with the recommendation of an independent data safety monitoring committee to continue SOPHIA as planned without modification. This analysis was based on a pre-specified assessment of progression-free survival as determined by independent central review. The Company also announced that the U.S. FDA had granted Fast Track designation for the investigation of margetuximab for treatment of patients with metastatic or locally advanced HER2 positive breast cancer who have previously been treated with anti-HER2-targeted therapy. MacroGenics remains on track to complete enrollment of the study by the end of 2018.
Phase 2 Gastric Cancer Study. In January 2018, MacroGenics presented interim clinical data from a Phase 2 study of margetuximab plus an anti-PD-1 agent in patients with gastric and gastroesophageal junction (GEJ) cancer. These results included encouraging tolerability, a 32% objective response rate and median progression-free survival of 5.5 months in a subpopulation of 25 patients with gastric cancer. Based on these results, MacroGenics is expanding the study by enrolling 25 additional gastric cancer patients and will continue to evaluate biomarkers to determine the patients who are most likely to benefit from margetuximab plus anti-PD-1 therapy.

Flotetuzumab. Recent highlights of the Company’s bispecific, humanized DART molecule that recognizes both CD123 and CD3, include:

Monotherapy Study. Updated data from an ongoing dose expansion study of flotetuzumab in patients with AML and myelodysplastic syndrome (MDS) were presented at the Annual American Society of Hematology (ASH) (Free ASH Whitepaper) Meeting in December 2017. Consistent with previously disclosed earlier dose escalation data, flotetuzumab demonstrated acceptable tolerability as well as evidence of anti-leukemic activity. MacroGenics continues to enroll the AML and MDS dose-expansion cohorts and anticipates presenting updated clinical data in 2018. The Company’s collaborator, Servier, has development and commercialization rights outside North America, Japan, Korea and India for flotetuzumab, also known as S80880.
Planned Combination Study with anti-PD-1. At the Annual ASH (Free ASH Whitepaper) Meeting in December 2017, MacroGenics presented data supporting the rationale for using checkpoint blockade as an approach to potentially enhance the anti-leukemic activity of flotetuzumab. MacroGenics intends to initiate a combination study with MGA012, an anti-PD-1 monoclonal antibody (mAb), by mid-2018.

Other Pipeline Assets Update

Additional programs that the Company is advancing include the following:

PD-1-Directed Immuno-Oncology Franchise. MacroGenics is advancing multiple PD-1-directed programs to enable both a broad set of combination opportunities across the Company’s portfolio and provide further differentiation from existing PD-1-based treatment options. These programs include:

MGA012. MGA012 is a humanized, proprietary anti-PD-1 monoclonal antibody being developed for use as monotherapy as well as in combination with other potential cancer therapeutics. MGA012 was licensed to Incyte Corporation in 2017 under a global collaboration and license agreement. Patients are being enrolled across multiple dose expansion cohorts in a Phase 1 study.
MGD013. MacroGenics designed a DART molecule, MGD013, to provide co-blockade of two immune checkpoint molecules expressed on T cells, PD-1 and LAG-3, for the potential treatment of a range of solid tumors and hematological malignancies. MGD013 is currently being evaluated in a Phase 1 dose escalation study. MacroGenics expects to establish the dose and schedule for MGD013 administration as well as initiate dose expansion cohorts in 2018.
MGD019. This DART molecule is designed to provide co-blockade of both PD-1 and CTLA-4 on T cells. The Company is completing Investigational New Drug (IND)-enabling studies and anticipates submitting the IND application for MGD019 in 2018.

B7-H3 Franchise. MacroGenics is developing a portfolio of therapeutics that target B7-H3, a member of the B7 family of molecules involved in immune regulation. The Company is advancing multiple programs that target B7-H3 through complementary mechanisms of action that take advantage of this antigen’s broad expression across multiple solid tumor types. These molecules include:

Enoblituzumab: The Company continues to recruit patients with various solid tumors in an ongoing study of this Fc-optimized monoclonal antibody that targets B7-H3, in combination with an anti-PD-1 mAb. The Company expects to present clinical data from this study in 2018.
MGD009: This DART molecule targeting B7-H3 and CD3 is being evaluated in a Phase 1 study across multiple solid tumor types. The Company expects to establish the dose and schedule for MGD009 administration as well as initiate monotherapy dose expansion cohorts in 2018. In addition, a combination study of MGD009 and MGA012 was recently initiated.
MGC018: The Company is completing IND-enabling activities to support submission of an IND application for this anti-B7-H3 antibody drug conjugate (ADC) in 2018.

Additional DART Clinical Programs. Additional DART molecules in Phase 1 clinical development being led by MacroGenics include the following:

MGD007. The Company is completing a monotherapy study of MGD007, a DART molecule that recognizes gpA33 and CD3, and anticipates commencing a combination study with MGA012 in 2018.
MGD014. MacroGenics’ first DART molecule designed to target an infectious agent, MGD014 recognizes the envelope protein of HIV-infected cells (Env) and the T cells’ CD3 component, to redirect the immune system’s T cells to kill HIV-infected cells. The Company expects to commence the Phase 1 study in 2018.

Corporate Update

Incyte Collaboration. In October 2017, MacroGenics announced that it had entered into a global collaboration and license agreement with Incyte. The Company received an upfront payment of $150 million upon closing in December 2017 and is eligible to receive milestones and royalties on any future sales of MGA012. MacroGenics retains the right to develop its own pipeline assets in combination with MGA012, with Incyte commercializing MGA012 and MacroGenics commercializing its combinatorial asset(s), if any such potential combinations are approved. In addition, MacroGenics retains the right to manufacture a portion of both companies’ global clinical and commercial supply needs of MGA012.
Roche Collaboration. In January 2018, MacroGenics announced that it had entered into a research collaboration and license agreement with F. Hoffmann-La Roche Ltd and Hoffmann-La Roche Inc. ("Roche") to jointly discover and develop novel bispecific molecules to undisclosed targets. MacroGenics received an upfront payment of $10 million from Roche in January 2018 and is eligible to receive potential milestone payments and royalties on future sales.
GMP Manufacturing Suite Build-out: The Company began the expansion of its manufacturing capacity in early 2017 by commencing the build-out of a GMP suite in its headquarters building in Rockville, Maryland to support larger-scale clinical and commercial manufacturing. MacroGenics expects this manufacturing suite to be fully operational in 2018.
Dr. Jay Siegel Added to Board. In November 2017, MacroGenics announced the appointment of Jay Siegel, M.D., former Chief Biotechnology Officer and Head of Scientific Strategy and Policy at Johnson & Johnson, to its Board of Directors.

2017 Financial Results and Cash Runway Guidance

Cash Position: Cash, cash equivalents and marketable securities as of December 31, 2017, were $305.1 million, compared to $285.0 million as of December 31, 2016.
Revenue: Total revenue, consisting primarily of revenue from collaborative agreements, was $157.7 million for the year ended December 31, 2017, compared to $91.9 million for the year ended December 31, 2016. Revenue from collaborative agreements includes the recognition of deferred revenue from payments received in previous periods as well as payments received during the year.
R&D Expenses: Research and development expenses were $147.2 million for the year ended December 31, 2017, compared to $122.1 million for the year ended December 31, 2016. This increase was primarily due to continued or expanded enrollment across multiple clinical trials as well as IND-enabling activities related to two preclinical product candidates.
G&A Expenses: General and administrative expenses were $32.7 million for the year ended December 31, 2017, compared to $29.8 million for the year ended December 31, 2016. This increase was primarily due to labor-related costs, including stock-based compensation expense, and information technology-related expenses, partially offset by lower patent expenses.
Net Loss: Net loss was $19.6 million for the year ended December 31, 2017, compared to net loss of $58.5 million for the year ended December 31, 2016.
Shares Outstanding: Shares outstanding as of December 31, 2017 were 36,859,077.
Cash Runway Guidance: MacroGenics expects that its current cash, cash equivalents and marketable securities, combined with anticipated funding under its current strategic collaborations, should fund the Company’s operations for approximately two years.

Acceleron Pharma has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, Acceleron Pharma, 2018, FEB 27, 2018, View Source [SID1234524200]).

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On February 27, 2018 TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, reported operating results for fourth-quarter and full-year 2017, and provided an update on the Company’s commercial products and development programs (Press release, TESARO, FEB 27, 2018, View Source [SID1234524265]).

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"Following its April 2017 introduction in the U.S., ZEJULA quickly became the market-leading PARP inhibitor for women with ovarian cancer, and in the second half of 2017, six out of ten ovarian cancer patients who were treated with a PARP inhibitor received ZEJULA," said Lonnie Moulder, CEO of TESARO. "Additionally, we are expanding the ZEJULA franchise with our ongoing launches in Europe and a focused clinical development program that utilizes both monotherapy and combination approaches to potentially further lengthen the time women with ovarian cancer are free from disease progression. 2018 will be an exciting year for our immuno-oncology portfolio as we anticipate multiple data readouts, including response data for TSR-042, our anti-PD-1 antibody, in patients with lung cancer and MSI-high tumors, initial results from the combination of TSR-022, our anti-TIM-3 antibody and TSR-042, and initial data from TSR-033, our anti-LAG-3 antibody."

Recent Business Highlights

ZEJULA is the most utilized PARP inhibitor among patients with ovarian cancer in the U.S., with more than 4,000 patients treated in 2017.
Following European Commission (E.C.) approval in November 2017, ZEJULA now has marketing authorization in 32 countries and is the first and only PARP inhibitor authorized for marketing in Europe for the maintenance treatment of patients with recurrent ovarian cancer, regardless of BRCA mutation status. ZEJULA has been launched in Germany and is available in the UK for private pay patients.
TESARO has applied to include ZEJULA in the UK’s Cancer Drug Fund (CDF) and will continue to work closely with the National Institute for Health and Care Excellence (NICE) and the National Health Service (NHS) England on the ZEJULA CDF submission to make this important medicine available as quickly as possible for a broad population of women in the UK.
The unit demand for VARUBI oral tablets increased 43% for Q4 2017 vs. Q4 2016, as the brand continues to penetrate the U.S. oral NK-1 market.
In January 2018, the package insert for VARUBI IV was updated to include mention of new adverse events, including anaphylaxis, anaphylactic shock and other serious hypersensitivity reactions, which were reported in the post-marketing setting following its introduction in late November 2017. Given these dynamics, TESARO believes the market opportunity is more limited than previously anticipated, and will suspend distribution of VARUBI IV while continuing to support VARUBI oral tablets. The Company is considering strategic alternatives for the product, including out-licensing, and will re-direct Company resources in support of ZEJULA.
Clinical trials of niraparib are ongoing to evaluate safety and efficacy in monotherapy and combination therapy for patients with ovarian, breast, and lung cancer:
PRIMA: Phase 3 trial for patients with first-line ovarian cancer will complete enrollment in Q2 2018
QUADRA: Registrational trial for patients with ovarian cancer who have received three or more prior lines of chemotherapy; top-line data will be available in Q1 and an abstract has been submitted to ASCO (Free ASCO Whitepaper)
TOPACIO: Phase 2 trial in combination with anti-PD-1 for patients with platinum-resistant ovarian cancer (data to be presented at SGO) or triple negative breast cancer (abstracts submitted to ASCO (Free ASCO Whitepaper))
AVANOVA: Phase 2 trial in combination with bevacizumab for patients with recurrent ovarian cancer; data are anticipated to be available in 2H 2018 to support an abstract submission
Niraparib tablet: A study is ongoing to advance development of a tablet formulation of niraparib
OVARIO: Phase 2 assessing niraparib in combination with bevacizumab for patients with newly diagnosed ovarian cancer
Janssen continues to advance development of niraparib in prostate cancer in monotherapy and combination therapy.
Zai Lab is advancing the development of niraparib in patients with ovarian, breast and lung cancer in China, and Takeda has initiated development of niraparib in Japan.
TSR-042 is in a registration trial (GARNET) for MSI-high tumors.
An abstract has been submitted to AACR (Free AACR Whitepaper) that includes data from patients with lung and metastatic microsatellite instability-high (MSI-H) cancers
Data are being generated to support the use of TSR-042 in registration studies in multiple tumor types, including lung, breast and ovarian cancer
Clinical trials are ongoing to evaluate TSR-022 (anti-TIM-3 antibody) and TSR-033 (anti-LAG-3 antibody) in combination with TSR-042.
AMBER: Phase 1 trial of TSR-022 in combination with TSR-042 is enrolling three tumor specific cohorts
CITRINO: Phase 1 dose-escalation trial of TSR-033
A retrospective, exploratory analysis of the NOVA trial, presented as part of a Satellite Symposium at the International Meeting of the European Society of Gynaecological Oncology (ESGO) in November 2017 in Austria, identified body weight and baseline platelet counts as the two most significant predictors for grade 3/4 thrombocytopenia.
In November, preliminary Phase 1 data presented at the 2017 Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) demonstrated TSR-022 is well tolerated across multiple dose levels, with a safety and efficacy profile expected for checkpoint inhibitors.
TESARO entered into a definitive term loan agreement for up to $500 million with Pharmakon Advisors, LP in November 2017, and drew $300 million in December 2017.

2017 Financial Results

TESARO reported total revenue for the fourth quarter of 2017 of $48.0 million, compared to $4.9 million for the same period in 2016. Revenue growth was primarily driven by the launch of ZEJULA in the U.S. in April 2017. Net loss for the fourth quarter of 2017 totaled $182.1 million, or ($3.35) per share, compared to $136.2 million, or ($2.59) per share for the same period in 2016.

Full year 2017 total revenues were $223.3 million, compared to $58.0 million for 2016. Revenue growth was primarily driven by the launch of ZEJULA in the U.S. and the upfront payment received as part of the license agreement with Takeda in the third quarter. Net loss for 2017 totaled $496.1 million, or ($9.17) per share, compared to a net loss of $374.2 million, or ($7.85) per share, for 2016.
(in thousands, except per share amounts) Three Months Ended
December 31, Twelve Months Ended
December 31,
2016
2017
2016
2017

Product revenue, net
ZEJULA - $ 43,436 - $ 108,756
VARUBI/VARUBY $ 2,330 $ 4,541 $ 5,174 $ 11,944
Total product revenue, net $ 2,330 $ 47,977 $ 5,174 $ 120,700
License, collaboration, and other revenue $ 2,591 $ 46 $ 52,844 $ 102,626
Total revenues $ 4,921 $ 48,023 $ 58,018 $ 223,326

Net loss $ (136,240 ) $ (182,065 ) $ (374,224 ) $ (496,126 )

Net loss per share, basic and diluted $ (2.59 ) $ (3.35 ) $ (7.85 ) $ (9.17 )

Product Revenue

Net product sales totaled $48.0 million for the fourth quarter of 2017, and included ZEJULA sales of $43.4 million and VARUBI/VARUBY sales of $4.5 million. This compares to net product sales of $2.3 million for the fourth quarter of 2016. The increase was primarily driven by the launch of ZEJULA in the U.S. in April 2017.

Net product sales for 2017 totaled $120.7 million and included ZEJULA sales of $108.8 million and VARUBI/Y sales of $11.9 million. For 2016, net product sales were $5.2 million.

Other Revenue

License, collaboration and other revenues for 2017 totaled $102.6 million and included the $100.0 million up-front payment received as part of the license agreement with Takeda in the third quarter. For 2016, license, collaboration, and other revenues were $52.8 million and included up-front payments received as part of the license agreements with Zai Lab and Janssen.

Operating Expenses
(in thousands) Three Months Ended
December 31, Twelve Months Ended
December 31,
2016 2017 2016 2017
Cost of sales – product $ 512 $ 30,857 $ 1,203 $ 41,137
Cost of sales – intangible asset amortization $ 464 $ 1,435 $ 1,855 $ 6,158
Research and development (R&D) $ 71,514 $ 97,832 $ 235,144 $ 308,742
Selling, general and administrative (SG&A) $ 54,526 $ 90,569 $ 158,578 $ 336,808
Acquired in-process R&D $ 9,000 $ 3,000 $ 18,940 $ 10,000

For the fourth quarter of 2017, compared to the same period in 2016:

Cost of sales associated with product sales increased to $30.9 million compared to $0.5 million, primarily due to the commercial launch of ZEJULA in the U.S., and inventory write-downs and other charges of $20.3 million related to revised expectations for future VARUBI IV revenue.

Cost of sales associated with intangible asset amortization increased to $1.4 million compared to $0.5 million primarily due to the amortization of milestones recorded upon FDA and European Commission approval of ZEJULA and first commercial sale of VARUBY in Europe.

R&D expenses increased to $97.8 million compared to $71.5 million primarily due to higher manufacturing costs associated with TSR-042 and TSR-022, the expansion of the niraparib, TSR-042 and TSR-022 clinical development programs, and increased headcount.

SG&A expenses increased to $90.6 million compared to $54.5 million primarily due to increased sales and marketing headcount, activities in support of the launches of ZEJULA and VARUBI/Y in the U.S. and Europe, and higher professional service fees.

Acquired in-process R&D expenses totaled $3.0 million compared to $9.0 million and included a milestone payment related to our immuno-oncology portfolio.

Operating expenses include total non-cash, stock-based compensation expense of $23.5 million, compared to $14.4 million.

For full-year 2017, compared to 2016:

Cost of sales associated with product sales increased to $41.1 million compared to $1.2 million primarily due to the commercial launch of ZEJULA in the U.S., and inventory write-downs and other charges related to revised expectations for future VARUBI IV revenue.

Cost of sales associated with intangible asset amortization increased to $6.2 million compared to $1.9 million primarily due to the amortization of milestones recorded upon FDA and E.C. approvals of ZEJULA and first commercial sale of VARUBY in Europe.

R&D expenses increased to $308.7 million compared to $235.1 million due to increased headcount, higher manufacturing costs associated with TSR-042 and TSR-022, the expansion of the niraparib, TSR-042 and TSR-022 clinical development programs, and the advancement of our earlier-stage immuno-oncology portfolio.

SG&A expenses increased to $336.8 million compared to $158.6 million due to increased sales and marketing headcount, activities in support of the launches of ZEJULA and VARUBI/Y in the U.S. and Europe, and higher professional service fees.

Acquired in-process R&D expenses totaled $10.0 million and included milestone payments related to our immuno-oncology portfolio, compared to $18.9 million, which included milestone payments related to ZEJULA and our immuno-oncology portfolio.

Operating expenses include total non-cash, stock-based compensation expense of $90.4 million compared to $48.5 million.

Cash and Cash Equivalents

As of December 31, 2017, TESARO had approximately $643.1 million in cash and cash equivalents and approximately 54.5 million outstanding shares of common stock.

2018 Financial Guidance

In 2018, TESARO expects:
Total Revenue, net, worldwide (FY) $310 to $345 million
ZEJULA (FY) $255 to $275 million
ZEJULA (Q1) $45 to $50 million
Other revenue, including licensing and VARUBI/Y oral (FY) $55 to $70 million
Interest expense (FY) $50 to $60 million, including non-cash interest expense of $14 million

In addition, TESARO anticipates its cash and cash equivalents balance to decline by $150 million during the first quarter. Quarterly declines in cash and cash equivalents are expected to moderate over the course of 2018, and in the fourth quarter of 2018, the decline in cash and cash equivalents balance is expected to be approximately $75 million. The Company plans to draw $200 million in 2018 from its available term loan facility. TESARO anticipates year-end 2018 cash and cash equivalents to be approximately $400 million.

Key Development Milestones

TESARO intends to achieve the following development milestones during 2018:

Ovarian Cancer Franchise:

Complete PRIMA enrollment in Q2 2018
Report TOPACIO platinum-resistant ovarian cancer data in 1H 2018
Initiate FIRST, a Phase 3 clinical trial of niraparib in combination with TSR-042 in first-line ovarian cancer, in 1H 2018
Report QUADRA data in 1H 2018 and submit sNDA in 2H 2018

Breast Cancer:

Report TOPACIO triple negative breast cancer data in 1H 2018
Publish BRAVO data in 2H 2018
Define registration path for niraparib in breast cancer in mid-2018

Lung Cancer:

Report initial data from lung cancer cohort of the GARNET trial of TSR-042 in NSCLC in 1H 2018
Initial data from Phase 2 JASPER study of niraparib in combination with an anti-PD-1 inhibitor to be available in 2H 2018

Prostate Cancer:

Janssen anticipates advancing trials of niraparib in prostate cancer to support U.S. and EU regulatory filings in 2019

Immuno-oncology Portfolio:

Complete enrollment in the MSI-high cohort of the GARNET trial to support a BLA submission to FDA in 2019
Report initial data for the AMBER trial of TSR-022 in combination with TSR-042 in 2H 2018 and define development strategy
Initiate assessment of the combination of TSR-033 plus TSR-042 in the CITRINO trial in Q2 2018 and report Phase 1 monotherapy dose-escalation data for TSR-033 in 2H 2018
Advance IND-enabling studies of PD-1/LAG-3 bi-specific (TSR-075)

Today’s Conference Call and Webcast
TESARO will host a conference call to discuss fourth quarter and full-year operating results and provide an update on its commercial products and development programs today at 4:15 P.M. Eastern time. The accompanying slide presentation and live webcast of the conference call can be accessed by visiting the TESARO website at www.tesarobio.com. The call can be accessed by dialing (877) 853-5334 (U.S. and Canada) or (970) 315-0307 (international). A replay of the webcast will be archived on the Company’s website for 30 days following the call.

About ZEJULA (Niraparib)
ZEJULA (niraparib) is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. In preclinical studies, ZEJULA concentrates in the tumor relative to plasma, delivering greater than 90% durable inhibition of PARP 1/2 and a persistent antitumor effect. Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML), including some fatal cases, was reported in patients treated with ZEJULA. Discontinue ZEJULA if MDS/AML is confirmed. Hematologic adverse reactions (thrombocytopenia, anemia and neutropenia), as well as cardiovascular effects (hypertension and hypertensive crisis) have been reported in patients treated with ZEJULA. Monitor complete blood counts to detect hematologic adverse reactions, as well as to detect cardiovascular disorders, during treatment. ZEJULA can cause fetal harm and females of reproductive potential should use effective contraception. Please see full prescribing information, including additional important safety information, available at www.zejula.com.

On February 27, 2018 Nordic Nanovector ASA (OSE: NANO) reported results for the fourth quarter and full year 2017 (Press release, Nordic Nanovector, FEB 27, 2018, View Source [SID1234553510]). A presentation by the company’s team will take place today in Oslo at 08:30 CET, see details below.

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Nordic Nanovector made significant progress during 2017, continuing the strong positive momentum started in 2016. The company has advanced the clinical development programme for Betalutin into its pivotal PARADIGME trial and expanded the knowledge base from which it intends to develop a successful commercialisation strategy for the candidate. The company also advanced its partnered early stage programmes aimed at creating a pipeline of novel targeted therapies for haematological cancers.

Updated clinical data from the Phase 1/2a LYMRIT 37-01 trial presented at ASH (Free ASH Whitepaper) in December continue to highlight Betalutin’s strong clinical profile as a single agent for treating patients with relapsed/refractory follicular lymphoma (R/R FL). Nordic Nanovector initiated its pivotal PARADIGME trial with Betalutin in the fourth quarter as planned and the study is currently open for patient enrolment. PARADIGME is a global randomized Phase 2b study comparing two Betalutin dosing regimens in third line (3L) FL patients who are refractory to standard-of-care anti-CD20-based therapy (including rituximab). Nordic Nanovector is targeting initial data read-outs from the study and subsequent filing in the second half of 2019 for marketing approval.

The final design for ARCHER-1 was completed and the trial will open for enrolment once regulatory approval has been received. The trial will be the first to combine Betalutin with rituximab in second line (2L) FL patients, based on promising preclinical data showing strong synergy between the two agents.

Recruitment into the Phase 1 study in diffuse large B-Cell lymphoma (DLBCL) remains on track, and a Phase 1 trial of Humalutin is ready to start with the first patient expected to be dosed in the second half of 2018.

Luigi Costa, CEO of Nordic Nanovector, comments: "In 2017 we continued with a strong momentum and have delivered on several important milestones. We continue to show strong clinical data that consistently reinforce Betalutin’s potential as one of the most promising new treatments for indolent non-Hodgkin Lymphoma (iNHL). We have transitioned the company to the next phase by starting PARADIGME, the pivotal Phase 2b study with the intent to generate the data for regulatory submission in 3L FL. I am very pleased with the good progress towards the first trial of Betalutin in combination with standard of care anti-CD20 therapy (rituximab) in 2L FL (ARCHER-1). Our focus during 2018 will be to drive recruitment into our leading clinical studies with the objective of taking Betalutin to patients as fast as possible while we progress in development of our commercial strategy."

Operational Highlights Q4’17

• Updated results from LYMRIT 37-01 Phase 1/2a trial presented at ASH (Free ASH Whitepaper) show Betalutin’s strong clinical profile in patients with R/R iNHL

o Significant anti-tumour activity observed: 90% of patients (n=59) had a reduction in tumour size

o ORR of 60% and CR of 24% for all evaluable iNHL patients

o Highly active in target population of FL patients with two or more prior therapies (3L FL) with 66% ORR and 25% CR

o Median duration of response of 13.3 months for FL patients receiving 40 mg lilotomab pre-dosing followed by 15 MBq/kg Betalutin (n=17); median duration of response of 22.9 months for patients with a CR (n=7)

o Promising early data from second dosing regimen (Arm 4 – 100 mg/m2 lilotomab/20 MBq/kg Betalutin)

o Well tolerated with predictable and manageable safety profile

• Phase 1/2a study LYMRIT 37-01 recruitment completed with 74 patients enrolled

• Pivotal Phase 2b PARADIGME trial initiated to investigate Betalutin in patients with 3L R/R FL

o Study opened for patient enrolment

o Two promising dosing regimens to be evaluated (40mg lilotomab/15 MBq/kg Betalutin and 100 mg/m2 lilotomab/20 MBq/kg Betalutin)

• Finalised design for ARCHER-1, trial aims to investigate Betalutin in combination with rituximab in 2L FL

o Trial will open for patient enrolment once regulatory approvals has been received

• Results from extensive research aimed at supporting market strategy for Betalutin demonstrate clear commercial opportunities

• Rosemarie Corrigan appointed to the Executive management team as Chief Quality Officer

Events after Q4’17

• Malene Brondberg appointed as Vice President, IR and Corporate Communications

Financial Highlights Q4 and FY’17

(Figures in brackets = same period 2016 unless otherwise stated)

• Revenues for the fourth quarter amounted to NOK 0.1 million (NOK 0.1 million). Revenues for the full year 2017 were NOK 0.3 million (NOK 0.3 million).

• Total operating expenses for the fourth quarter were NOK 102.0 million (NOK 65.4 million). Total operating expenses for the full year 2017 amounted to NOK 316.8 million (NOK 216.7 million).

• Comprehensive loss for the fourth quarter amounted to NOK 87.6 million (loss of NOK 59.3 million). Comprehensive loss for the full year 2017 was NOK 295.6 million (NOK 235.8 million).

• Cash and cash equivalents amounted to NOK 756.6 million at the end of December 2017 (NOK 1 018.2 million).

Outlook

Nordic Nanovector aspires to become a leader in the field of Precision Therapies for haematological cancers by developing, manufacturing and commercialising innovative therapies to address major unmet medical needs and advance cancer care.

Betalutin, the company’s most advanced product candidate, is developing a well differentiated, competitive, clinical profile for R/R FL, based on the promising preliminary results from the LYMRIT 37-01 Phase 1/2a clinical study. The company’s pivotal Phase 2b PARADIGME trial with Betalutin in 3L R/R FL is underway with the goal to have the initial data read-outs from the study and subsequent filing in the second half of 2019 for marketing approval.

Nordic Nanovector intends to maximize the value of Betalutin across other stages of FL, NHL and other haematological cancer indications. A further element of the company’s strategy is to selectively extend its pipeline of novel targeted biopharmaceutical candidates to support future growth.

Management will continue to focus its efforts on the efficient execution of its plans and to meet clinical and pre-commercialisation milestones. The company is confident that Betalutin could become an attractive and convenient therapeutic option, which, based on detailed market research, has the potential to be commercially successful.

Current cash resources are expected to be sufficient until first regulatory filing of Betalutin in 3L R/R FL and to advance other key programmes

Presentation and webcast – Fourth Quarter and Full Year 2017 results

A presentation by Nordic Nanovector’s senior management team will take place today at 8:30 am CET at:

Thon Hotel Vika Atrium, Munkedamsveien 45, 0250 Oslo

Meeting Room: NYLAND

The presentation will be recorded as a webcast and will be available at www.nordicnanovector.com in the section: Investors & Media

The results report and the presentation will be available at www.nordicnanovector.com in the section: Investors & Media/Reports and Presentation/Interim Reports/2017 from 7:00 am CET today.

LabCorp has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, LabCorp, 2018, FEB 27, 2018, View Source [SID1234524201]).

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